The present invention relates in general to surgical trays and means to retain surgical instruments and related apparata on such trays. More particularly, the present invention relates to an autoclave tray wherein implanting tools and prosthetic members may be securely retained in a quiet and safe manner through all phases of autoclaving for sterilization of the tools and members.
One preliminary step to any surgical procedure is to have the surgical instruments and related components and accessories properly sterilized. This procedure involves subjecting the various parts and components to an autoclaving operation wherein these objects are subjected to an elevated temperature in the range of 270 degrees Fahrenheit and an elevated pressure. Prior to the autoclaving operation, the holder for the tools, instruments and components is turned or rotated as they are wrapped.
As should be understood, one requirement for the tray and holders for these instruments and components is that they be able to withstand the elevated temperatures and pressures and to do so for many cycles. Any tray and instrument holder which would become unsuitable for continued use after only a few autoclaving cycles represents a design inefficiency not only from the standpoint of cost but as well from the standpoint of inventory control and the time and inconvenience associated with having to constantly replace a damaged or otherwise unsuitable autoclaving tray.
As might be expected, the surgical instruments, devices and prosthetic components which must be sterilized before an operation are mounted onto an autoclaving tray and supported on the tray by means of retainers. Due to the elevated temperature and pressures, these trays and holders have traditionally always been constructed of some metal or metal alloy. Clearly, metal has been found to be a suitable material that can be subjected to numerous cycles of the autoclaving operation without showing signs of wear or damage. With the material selection problem solved, designers of autoclaving trays then turned to another concern. This other concern was how to configure the tray so that any tray could receive a variety of instruments and prosthetic components or similar items to be autoclaved when the requirements and component mix were not always the same. Not only would the types of instruments and components change, but the number of such components might be different for any surgical procedure and parts secured from different manufacturers might be sized slightly differently. As these differences would arise, not only would the autoclaving tray require some change or modification, but the design of the holders for the various instruments and components might also need to change or be designed in some manner so as to be variable and thus adaptable to various sizes and shapes.
One approach to the foregoing problem was to design what could be referred to as "universal" autoclaving trays and holders which were configured on the basis of a matrix screen having a uniformly spaced pattern of holder-receiving holes extending throughout the surface of the screen. By configuring the instrument holders of a diameter size to fit within the various matrix holes in the screen, it was possible to configure an autoclaving tray which could receive various-styled instruments in a variety of orientations and configurations. An example of this type of device is offered by the Sklar patent reference, U.S. Pat. No. 4,043,754 which issued Aug. 23, 1977. This reference focuses primarily on the design of a U-shaped pin for a sterilizing tray in order to hold surgical instruments during sterilization. The concept of Sklar relies primarily on a minimal push-in fit of the U-shaped pins into the various holes of the perforated metal bottom surface of the tray. One problem though is that this particular style of device does not offer a secure means of retaining surgical instruments as the tray may be turned or rotated so as to insure thorough sterilization. Even if the pins could be retained in the perforated metal surface during such turning and rotating procedures, very likely the instruments held by the pins would move about due to the height of the interior clearance within the U-shape relative to the location of the abutment stops on the pin which fix the vertical height of the pin above the perforated metal surface. While this increased vertical height within the U-shaped pin might be suitable for retaining more than one identical surgical instrument, such instruments would no doubt bang against each other during the turning and rotating of the wrapping procedure, and scratch or mar the respective surfaces. A great deal of noise would also be created by this movement and if critical prosthetic components were mounted, there would be a significant risk that precisely machined surfaces might come in contact with one another thereby dulling or nicking these critically machined surfaces or edges.
A somewhat related disclosure is found in the patent reference issued to Schainholz, U.S. Pat. No. 4,135,868 which issued Jan. 23, 1979. This particular patent reference discloses another perforated metal surface which allows the instrument holders to be inserted and arranged in an infinite variety of orientations and configurations. The holders themselves have a variety of shapes and sizes but are installed by means of push-in pins or buttons disposed along the bottom or lower surface of the respective holder. One concern of this particular design as previously addressed with the Sklar reference is the fact that turning and inverting during an autoclaving operation of only support surface 26 would cause the instruments to fall out of their respective holders or the holders to fall out of the perforated metal surface. To attempt to correct this design deficiency, the Schainholz patent discloses a top surface formed as part of a receptacle or box which is fitted with clamping pads or blocks. When the lid is closed over the bottom retaining surface which holds the surgical instruments, a plurality of rectangular blocks of heat resistant material of a rubber-like compound clamp against the various tools and instruments and hold them in position during the autoclaving operation.
What this design necessitates and one of the reasons why it is felt to be a significant disadvantage is that both a top and a bottom surface are required and must be held together by some type of receptacle or box construction. Further, one pair of holders for any particular surgical instrument is insufficient and there must be provided an additional pair of holders and the compressing rubber-like material pad in order to hold the instrument in place. As a result, not only is there a large number of pieces to arrange on the respective perforated metal surfaces, but these various items must be aligned with one another so that the rubber-like material pads properly compress the tools which are held in the lower surface by the various holders.
A further concern with this particular design is that two or more identical prosthetic implant components or surgical instruments cannot be stacked on top of each other due in part to the shallowness of the lower surface holders as well as due to the presence of the compressing pads as part of the upper surface. If such a stacked retention was attempted, the two instruments would be pushed into contact with each other resulting in the aforementioned problems of scratching, denting or marring which not only affects the appearance of the tools or instruments, but which would have a significant degrading effect on precisely cut and machined edges of the prosthetic implant components.
A third reference of which the inventor is aware, although one which is believed to have very limited relevancy to the present invention is the patent issued to McConahy, U.S. Pat. No. 354,799 which issued Dec. 21, 1886. This patent reference discloses a holder for rings, and its only relevancy to the present invention is believed to be in the fact that a variable holding apparatus is disclosed which appears to be capable of receiving variously sized and shaped components.
One very clear problem with the autoclaving apparata of both Sklar and Schainholz is the fact that what is disclosed is not considered to be a conventional and typically styled autoclaving tray. It is important in the design of such trays that their length and width dimensions be suitable not only for the autoclaving procedure, but for placement on an operating or surgical table in a secure and space-efficient manner. The overall height of the tray is also of some concern with regard to the autoclaving equipment and thus designs such as Sklar which may present an unusually high pin member would not be suitable. Similarly, the design of Schainholz would not be suitable, not only from the standpoint that its structure is unsuitable for conventional autoclaving equipment due to its size and cumbersome nature, but that it is as well unsuitable for placement in a surgical operating room because of its top lid and the surface area it occupies when opened.
A related problem with autoclaving trays of the universal design is that there is no uniformity or consistency of component part or surgical tool placement. Due to the number of hospital personnel which may be involved in securing the various components to be autoclaved, loading these components onto an autoclaving tray and then moving the components and tray into the surgical arena, there are numerous chances for errors or omissions. For example, since the universal autoclaving tray has no indication of what should be installed on it or where these items should be installed, every autoclaving cycle even of the same group of components may be arranged differently. If the autoclaving tray is then moved directly into the surgical arena, the operating room personnel will always be looking in a different location to try and find the components or instruments which they must use next. There is also some concern that for any one surgical procedure, such as a total hip or total knee replacement, all of the necessary components may not be provided.
The inventor is aware of an effort to alleviate this problem by configuring an autoclaving tray which is suitable to be transferred from the autoclaving operation directly into the surgical operating room. This tray includes a series of metal brackets which are riveted to the surface of the tray in fixed locations in order to retain a fixed group of surgical instruments and prosthetic implant components. This allows the autoclaving personnel as well as the surgical room personnel to quickly and easily identify not only what components must go where for the autoclaving, but enables the selection of those components quickly and easily once in the operating room. The top surface of the autoclaving tray is configured with instrument outline markings and component part identifications so that hospital personnel, regardless of their position in the cycle or their responsibility, will know what items should go on the tray and where these items should be placed. This allows tray after tray to be identically loaded and contain the proper complement of instruments and prosthetic implant component parts for any surgical procedure.
One concern with this type of device is the expense and time involved to rivet each of the metal brackets onto the autoclaving tray and the inability of a physician or surgeon to modify the tray by changing either the location or style of holders. A further problem with this particular device is that the holders are not capable of holding a plurality of identical components at the same location without them nicking, scratching or marring each other and deteriorating critically machined surfaces, a problem previously discussed. A still further problem with this particular style of autoclaving tray and holder is that the prosthetic component parts and surgical instruments, whether stacked singularly or in combination, will clatter and bang against the respective metal holders during any turning, moving or rotation of the tray and its contents during the wrapping procedure prior to autoclaving.
Each of the foregoing problems, shortcomings and disadvantages of what are believed to be the full range of prior devices are completely solved by the present invention. What the present invention offers is an autoclaving tray with fixed slots arranged throughout the top surface of the tray for receiving in a variety of locations synthetic material holders, wherein the tray contains screened-on markings of the outlines of the instruments and the prosthetic component parts, and the part numbers or similar nomenclature markings. The synthetic holders are designed such that they may either be manually snapped into respective slots which are disposed throughout the surface, or slidably inserted into the slots by means of an enlarged keyhole opening at one end of the slot. When the snap-in approach is used, the holders cannot be removed without partially or totally destroying the particular holder. With the slide-in approach, the holders are removable thereby allowing a holder to be removed, modified or reworked and then reinserted.
Each pin or screw holder is designed so as to retain two or more identical component parts without these parts coming in contact with one another. The particular holders may also be modified by the physician so as to accept a special or modified instrument, and the holders have a scratch-free, mar-free and quiet surface such that there is no damage to the components regardless of the movement of the tray during autoclaving and subsequent use in surgery, even if fully loaded with components. The tray is free of any top lid or upper clamping means thus relying solely on the shape and fit of the synthetic holders for retention of the pins, components and instruments which must be autoclaved. Once the autoclaving procedure is completed, the tray, holders and instruments may be moved directly into the operating room arena at which time the instruments and prosthetic component members may be removed as required by operating room personnel. It is readily apparent, from a visual inspection of the tray, whether or not all necessary components are present and properly located in accordance with the outline shape and corresponding nomenclature. A complete understanding of the present invention as well as the various benefits and improvements which it offers will be presented more fully by the descriptions which follow.